Home / 510(k) Clearances / K872245

510(k) K872245

PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM by General Electric Co. — Product Code IXC

K872245 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 19, 1987. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1987
Date Received
June 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Radiographic-Film
Device Class
Class I
Regulation Number
892.1890
Review Panel
RA
Submission Type

Other clearances by General Electric Co.

  • K110798 — SENOGRAPHE DS, SENOGRAPHE ESSENTIAL (December 22, 2011)
  • K103485 — SENOGRAPH DS, SENOGRAPH ESSENSTIAL (October 6, 2011)
  • K103489 — GE VEO RECONSTRUCTION OPTION (September 9, 2011)
  • K082317 — GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION (September 26, 2008)
  • K081921 — GE VIVID E9 ULTRASOUND (August 6, 2008)
  • K073297 — GE LOGIQ P6 (December 18, 2007)
  • K072952 — GE ECHOPAC (November 16, 2007)
  • K072797 — GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPAC (October 17, 2007)
  • K072075 — MODIFICATION TO GE LOGIQ A3 (August 29, 2007)
  • K071985 — GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND (August 17, 2007)

Other clearances for product code IXC

  • K991302 — SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS (June 1, 1999)
  • K973965 — SMART MOTORIZED VIEWER (December 12, 1997)
  • K973115 — ARRIPRO 35 ST/TV (September 2, 1997)
  • K970240 — DIFFUSER PANEL (March 11, 1997)
  • K954998 — LILY DARK VIEWER (January 29, 1996)
  • K954199 — VOXBOX (September 29, 1995)
  • K952188 — ADVIEWER 2000 (May 30, 1995)
  • K922848 — ULTRALITE X-RAY FILM ILLUMINATOR (September 28, 1992)
  • K922079 — ROTOLUX, SELECTOLUX, SHUTTERVUE (June 16, 1992)
  • K883702 — EXCELVIEW ILLUMINATOR (September 19, 1988)

FDA data resources